CompletedInterventionalPhase 1Updated Feb 23, 2024
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers | NCT01952548 | Trialant
CompletedInterventionalPhase 1Updated Dec 31, 2013
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers
ClinicalTrials.gov ID
NCT01952548
Lead Sponsor
Kowa Research Institute, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Last Update Posted
Dec 31, 2013Estimated
Start Date
May 2013
Primary Completion Date
Dec 2013Actual
Brief Summary
This study will test single doses of the study drug in increasing amounts to see if it is safe.
Safety and Tolerability
K-312
Placebo
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No data available
Eligibility Criteria
Inclusion Criteria:
Subject provides written informed consent before any study-specific evaluation is performed.
Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.
Exclusion Criteria:
Subject is a woman who is of childbearing potential or is breastfeeding.
Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.